NCT02214563

Cholecalciferol Supplementation for Anemia and Mineral and Bone Disorder in Hemodialysis Patients

Cholecalciferol Supplementation for Anemia and Mineral and Bone Disorder in Hemodialysis Patients (CHAMBER): A Multicenter, Double-blind, Randomized, Placebo-controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Takayuki Hamano · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether cholecalciferol supplementation decrease the blood concentrations of hepcidin-25 in hemodialysis patients.

Detailed description

There are 4 arms in this study: (1) Thrice-weekly cholecalciferol supplementation (3,000 IU), (2) Monthly cholecalciferol supplementation (equivalent to 9,000/week), (3) Thrice-weekly placebo, and (4) Monthly placebo. The primary analyses will be done regarding 2 cholecalciferol groups and 2 placebo groups as one group each, and we will evaluate the effect of cholecalciferol regardless of the supplementation regimen. As the secondary analyses, we will examine if there is any difference between thrice-weekly and once-monthly supplementation regimen.

Conditions

• Kidney Failure, Chronic
• Anemia
• Vitamin D Deficiency
• Bone Diseases, Metabolic

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Cholecalciferol	Made for this trial by Molecular Physiological Chemistry Laboratory, Inc.
DIETARY_SUPPLEMENT	Olive oil

Timeline

• Start date: 2014-08-01
• Primary completion: 2016-03-01
• Completion: 2016-12-01
• First posted: 2014-08-12
• Last updated: 2018-08-31

Locations

7 sites across 1 country: Japan